,i #aafth ,,congress #ast ,session ,h4 ,r4 #dhff ,,in ,,the ,,house ,,of ,,representatives ,october #bh1 #bjai,mr4 ,pallone 7for himself and ,mr4 ,guthrie7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the #bast ,century ,cures ,act to provide for designation of institutions of higher education that provide research1 data1 and leadership on continuous manufacturing as ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing ,act of #bjai4 #b4 ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h7 is amended to read as follows3 #cjaf4 ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs-- 7#a7 shall solicit and1 beginning not later than #ahj days after the date of enactment of the ,national ,centers of ,excellence in ,continuous ,pharmaceutical ,manufacturing ,act of #bjai1 receive requests from institutions of higher education to be designated as a ,national ,center of ,excellence in ,continuous ,pharmaceutical ,manufacturing 7in this section referred to as a ,national ,center of ,excellence7 to support the advancement and development of continuous manufacturing2 and 7#b7 shall so designate any institution of higher education that-- 7,a7 requests such designation2 and 7,b7 meets the criteria specified in subsection 7c74 7b7 ,request for designation ,a request for designation under subsection 7a7 shall be made to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 ,any such request shall include a description of how the institution of higher education meets or plans to meet each of the criteria specified in subsection 7c74 7c7 ,criteria for designation described ,the criteria specified in this subsection with respect to an institution of higher education are that the institution has1 as of the date of the submission of a request under subsection 7a7 by such institution-- 7#a7 physical and technical capacity for research and development of continuous manufacturing2 7#b7 scalable manufacturing knowledge-sharing networks with other institutions of higher education1 large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other entities2 7#c7 proven capacity to design and demonstrate new1 highly effective technology for use in continuous manufacturing2 7#d7 a track record for creating and transferring knowledge with respect to continuous manufacturing2 7#e7 the potential to train a future workforce for research on and implementation of continuous manufacturing2 and 7#f7 the potential to participate in and lead a continuous manufacturing technology partnership with other institutions of higher education1 large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other entities-- 7,a7 to support companies with continuous manufacturing in the ,united ,states2 7,b7 to support ,federal agencies with technical assistance for continuous manufacturing2 7,c7 with respect to continuous manufacturing1 to organize and conduct research and development activities needed to create new and more effective technology1 capture and disseminate expertise1 create intellectual property1 and maintain technological leadership2 7,d7 to standardize systems and approaches for designing continuous manufacturing2 and 7,e7 to develop a plan to establish a continuous manufacturing workforce4 7d7 ,termination of designation ,the ,secretary may terminate the designation of any ,national ,center of ,excellence designated under this section if the ,secretary determines such ,national ,center of ,excellence no longer meets the criteria specified in subsection 7c74 ,not later than #fj days before the effective date of such a termination1 the ,secretary shall provide written notice to the ,national ,center of ,excellence1 including the rationale for such termination4 7e7 ,conditions for designation ,as a condition of designation as a ,national ,center of ,excellence under this section1 the ,secretary shall require that an institution of higher education enter into an agreement with the ,secretary under which the institution agrees-- 7#a7 to collaborate directly with the ,food and ,drug ,administration to publish the reports required by subsection 7g72 7#b7 to share data with the ,food and ,drug ,administration regarding best practices and research generated through the funding under subsection 7f72 7#c7 to provide an annual report to the ,food and ,drug ,administration regarding the institution's activities under this section2 and 7#d7 to develop1 along with industry partners and another institution or institutions designated under this section1 if any1 a roadmap for developing a continuous manufacturing workforce4 7f7 ,funding 7#a7 ,in general ,the ,secretary shall award funding to the ,national ,centers of ,excellence designated under this section for the purpose of studying and recommending improvements to continuous manufacturing1 including such improvements as may enable the ,centers-- 7,a7 to continue to meet the conditions specified in subsection 7e72 7,b7 to submit reports under subsection 7e77#c72 and 7,c7 to expand capacity for research on1 and development of1 continuing manufacturing4 7#b7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this subsection #hj1jjj1jjj for the period of fiscal years #bjba through #bjbe4 7#c7 ,rule of construction ,nothing in this section shall be construed as precluding a ,national ,center for ,excellence designated under this section from receiving funds under any other provision of this ,act or any other ,federal law4 7g7 ,annual review and reports 7#a7 ,annual report ,beginning not later than one year after the date on which the first designation is made under subsection 7a71 and annually thereafter1 the ,secretary shall-- 7,a7 submit to ,congress a report describing the activities1 partnerships and collaborations1 ,federal policy recommendations1 previous and continuing funding1 and findings of1 and any other applicable information from1 the ,national ,centers of ,excellence designated under this section2 and 7,b7 make such report available to the public in an easily accessible electronic format on the website of the ,food and ,drug ,administration4 7#b7 ,review of national centers of excellence and potential designees ,the ,secretary shall periodically review the ,national ,centers of ,excellence designated under this section to ensure that such ,national ,centers of ,excellence continue to meet the criteria for designation under this section4 7#c7 ,report on long-term vision of ,,fda role ,not later than #b years after the date on which the first designation is made under subsection 7a71 the ,secretary1 in collaboration with the ,national ,centers of ,excellence designated under this section1 shall submit a report to the ,congress on the long-term vision of the ,department of ,health and ,human ,services on the role of the ,food and ,drug ,administration in supporting continuous manufacturing1 including-- 7,a7 a national framework of principles related to the implementation and regulation of continuous manufacturing2 and 7,b7 a plan for the development of ,federal regulations and guidance for how continuous manufacturing can be incorporated into the development1 review1 and approval process for drugs and biological products4 7h7 ,definitions ,in this section3 7#a7 ,biological product ,the term biological product has the meaning given such term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#b7 ,continuous manufacturing ,the term continuous manufacturing-- 7,a7 means a process where the input materials are continuously fed into and transformed within the process1 and the processed output materials are continuously removed from the system2 and 7,b7 consists of an integrated process that consists of a series of two or more unit operations4 7#c7 ,drug ,the term drug has the meaning given such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#d7 ,institution of higher education ,the term institution of higher education has the meaning given such term in section #aja7;a7 of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja7;a774 7#e7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4 4 7b7 ,transition rule ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h71 as in effect on the day before the date of the enactment of this section1 shall apply with respect to grants awarded under such section before such date of enactment4